NEUROFORM ATLAS 4.0MM X 15MM NO TIP - CE

Additional Manufacturer Narrative

DUE TO THE AUTOMATED MES (MANUFACTURING EXECUTION SYSTEM) SYSTEM THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. VISUAL/MICROSCOPIC INSPECTION WAS PERFORMED AS THE SUBJECT STENT WAS RECEIVED DEPLOYED WITHIN THE LUMEN OF A NON-STRYKER BALLOON CATHETER. THE STENT DELIVERY WIRE (SDW) WAS RETURNED, THE INTRODUCER SHEATH WAS NOT RETURNED. THE MICROCATHETER WAS CUT IN ORDER TO REMOVE THE STENT. THE SUBJECT STENT WAS BROKEN/FRACTURED, THE PROXIMAL END WAS RETRIEVED. THE DISTAL END WAS NOT LOCATED WITHIN THE BALLOON CATHETER. THE SDW WAS KINKED/BENT AT THE DISTAL END, AND STRETCHED. FUNCTIONAL INSPECTION WAS UNABLE TO PERFORM AS THE SUBJECT STENT WAS RETURNED IN A DEPLOYED STATE. THE AS REPORTED EVENT 'STENT DEPLOYED PREMATURELY DURING USE' WAS CONFIRMED DURING DEVICE INSPECTION. THE REMAINING REPORTED ¿STENT DIFFICULT/UNABLE TO ADVANCE OR PULLBACK THROUGH CATHETER' COULD NOT BE REPLICATED AS THE SUBJECT STENT WAS NO LONGER LOADED ON THE SDW. HOWEVER, THE ANALYSIS RESULTS ARE CONSISTENT WITH THE REPORTED EVENT. THE SUBJECT DEVICE FAILED TO MEET SPECIFICATIONS WHEN RECEIVED FOR COMPLAINT INVESTIGATION BASED ON THE ANALYZED ANOMALY NOTED TO THE DEVICE. THE REPORTED EVENT IS COVERED IN THE DEVICE DIRECTIONS FOR USE (DFU). AS WELL, THE RISK OF THE REPORTED EVENT IS DOCUMENTED IN THE RISK DOCUMENTATION AND THERE ARE CURRENT CONTROLS TO MITIGATE THE RISK OF THE AS REPORTED EVENT. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER INDICATED THAT THE SUBJECT DEVICE WAS PREPARED AS PER THE DFU. THERE WAS NO DAMAGE NOTED TO THE PACKAGING PRIOR TO OPENING THE PACKAGING AND THE DEVICE WAS CONFIRMED TO BE IN GOOD CONDITION PRIOR TO USE ON THE PATIENT. CONTINUOUS FLUSH WAS SET UP AND MAINTAINED THROUGHOUT THE CLINICAL PROCEDURE. THE SUBJECT STENT WAS RETURNED FOR ANALYSIS WITH PART OF THE SUBJECT STENT VISIBLE INSIDE THE HUB OF A NON-STRYKER BALLOON CATHETER AND PART OF THE SUBJECT STENT DEPLOYED INSIDE THE PROXIMAL LUMEN OF THE CATHETER. IT WAS NECESSARY TO CUT THE CATHETER IN ORDER TO REMOVE THE SUBJECT STENT. ONCE REMOVED THE SUBJECT STENT WAS NOTED TO BE DEFORMED AND ALSO BROKEN/FRACTURED. ONLY THE PROXIMAL END OF THE SUBJECT STENT COULD BE LOCATED IN THE CATHETER. THE SDW WAS RETURNED FOR ANALYSIS AND WAS KINKED/BENT AND STRETCHED TOWARDS THE DISTAL END OF THE WIRE. THE INTRODUCER SHEATH WAS NOT RETURNED FOR ANALYSIS. THE INTERNAL HUB PROFILE OF THE EXCELSIOR SL-10 MICROCATHETER IS AN EXACT MATCH FOR THE EXTERNAL PROFILE OF THE DISTAL TIP OF THE SUBJECT INTRODUCER SHEATH. CORRECTLY PLACEMENT OF THE INTRODUCER SHEATH DISTAL TIP INTO THE HUB OF THIS MICROCATHETER WILL THEREFORE ENSURE EASE OF TRANSFER OF THE SUBJECT STENT FROM THE SHEATH INTO THE MICROCATHETER LUMEN. IT IS HIGHLY UNLIKELY THAT THE INTERNAL PROFILE OF THE NON-STRYKER BALLOON CATHETER IS AN EXACT MATCH FOR THE INTRODUCER SHEATH DISTAL TIP. BASED ON THE EVENT DESCRIPTION AND ANALYSIS RESULTS, IT IS POSSIBLE THAT THE INTRODUCER SHEATH WAS POSITIONED SLIGHTLY PROXIMALLY WITHIN THE HUB OF THE NON-STRYKER BALLOON CATHETER, OR IT WAS INITIALLY CORRECTLY POSITIONED BUT SUBSEQUENTLY MOVED PROXIMALLY PRIOR TO SUBJECT STENT ADVANCEMENT OUT OF THE SHEATH. IF THIS WERE TO OCCUR, IT IS LIKELY THAT, DURING ADVANCEMENT OF THE SUBJECT STENT TO TRANSFER IT FROM THE SHEATH INTO THE PROXIMAL END OF THE CATHETER LUMEN, THE SUBJECT STENT WOULD PARTIALLY DEPLOY INTO THE GAP (CAUSED BY THE PROXIMAL SHEATH MOVEMENT). THE USER WOULD, AS A CONSEQUENCE, EXPERIENCE RESISTANCE DURING ATTEMPTS TO ADVANCE THE SUBJECT STENT INTO THE CATHETER LUMEN. UPON REALIZING THIS, THE USER NORMALLY ATTEMPTS TO WITHDRAW THE SUBJECT STENT. DURING THIS ACTION, THE SUBJECT STENT APPEARS TO HAVE BECOME DEPLOYED INSIDE THE HUB AND THE LUMEN OF THE BALLOON CATHETER. THIS IS THE MOST LIKELY EXPLANATION FOR THE DAMAGE/OBSERVATIONS NOTED DURING ANALYSIS AND THE INFORMATION PROVIDED IN THE EVENT DESCRIPTION. WHAT IS UNCLEAR IS HOW THE SUBJECT STENT BECAME SO DAMAGED THAT IT BROKE/FRACTURED. AND IT IS ALSO UNCLEAR WHERE THE DISTAL PART OF THE SUBJECT STENT HAD GONE. AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS HAS BEEN ASSIGNED TO THE AS REPORTED: (STENT DIFFICULT/UNABLE TO ADVANCE OR PULLBACK THROUGH CATHETER AND STENT DEPLOYED PREMATURELY DURING USE) AND AS ANALYZED: (STENT DEPLOYED PREMATURELY DURING USE, STENT DEFORMED, STENT BROKEN/FRACTURED DURING USE, SDW KINKED/BENT AND SDW DEFORMED) AS THIS COMPLAINT APPEARS TO BE ASSOCIATED WITH A PRODUCT THAT MET STRYKER DESIGN AND MANUFACTURING SPECIFICATIONS AND WAS USED IN ACCORDANCE WITH THE DFU, BUT PERFORMANCE WAS LIMITED DUE TO PROCEDURAL FACTORS DURING USE.

Description of Event or Problem

IT WAS REPORTED THAT DURING ONE MIDDLE CEREBRAL ARTERY (MCA) STENOSIS INTERVENTIONAL PROCEDURE, AFTER BALLOON DILATION, THE PHYSICIAN DELIVERED PLANNED TO PERFORM STENT ANGIOPLASTY USING THE BALLOON CATHETER. WHEN DELIVERING THE SUBJECT STENT INTO THE HUB OF THE BALLOON CATHETER, THE SUBJECT STENT MET BIG RESISTANCE AT ITS TIP. DURING ADJUSTMENTS, HALF OF THE SUBJECT STENT WAS INSIDE THE HUB OF MICROCATHETER AND THE OTHER HALF WAS DEPLOYED. THE SUBJECT DEVICE WAS REMOVED AND REPLACED WITH ANOTHER ONE IN SAME CATALOG AND USED MICROCATHETER TO DELIVER AND DEPLOYED SUCCESSFULLY TO FINISH THE PROCEDURE. THERE WERE NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.